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User Manual
August 2009, Revision 07
User Manual
August 2009, Revision 07
© 2007-2009 Radiancy Inc. All right reserved.
Mistral User Manual, August 2009. Part Number: 2011580. Revision 07
Note: The information in this document is confidential and proprietary. It is provided to
customers and authorized representatives of Radiancy only. The content of this manual is
furnished for informational use only, is subject to change without notice and should not be
construed as a commitment by Radiancy Inc.
LHE is a registered trademark of Radiancy Inc. in the United States and/or in other countries.
The Quality Management System of Radiancy Ltd. complies with the Quality Management
Standard ISO 13485-2003.
Manufacturer: Radiancy (Israel) Ltd., 5 Hanagar St., P.O. Box 7329, Hod
Hasharon, 45240, Israel, Tel: 972-9-775-7500, Fax: 972-9-775-7511
www.radiancy.com
Authorized European Representative: Obelis S.A,, Av. de Tervuren
34 Bte .44, B-1040 Brussels, Belgium. Tel: 32 (0) 2 732 5954, Fax: 32
(0) 2 732 6003, GSM 07545 4660, e-mail: [email protected]
KEMA Notified Body.
Contact Information
Customer satisfaction is a Radiancy priority. To help us in providing you with
the best possible product and support, please send us your comments and
suggestions. Contact us at the addresses and telephone numbers below:
US
Radiancy Inc.
40 Ramland Road South, Suite 200
Orangeburg, NY 10962
USA
Toll Free: 888 661-2220
Tel: +1 845 398-1647
Fax: +1 845 398-1648
E-mail: [email protected]
ii
Israel
Radiancy (Israel) Ltd.
5 Hanagar St., P.O. Box 7329
Hod Hasharon, 45240
Israel
Tel: +972-9-775-7500
Fax: +972-9-775-7511
E-mail: [email protected]
Table of Contents
1. INTRODUCTION TO THE SYSTEM
1
2. SYSTEM DESCRIPTION
2
2.1. SYSTEM COMPONENTS AND CONTROLS:........................................2
2.2. MAJOR PRECAUTIONS & WARNINGS ..............................................7
3. INITIAL SET UP
14
3.1. UNPACKING MISTRAL ....................................................................14
3.2. ELECTRICAL REQUIREMENTS ........................................................14
3.3. INSTALLATION ..............................................................................15
4. OPERATION AND TREATMENT PROTOCOLS
17
4.1. GENERAL GUIDELINES FOR THE OPERATION OF MISTRAL ................17
4.2. USING THE TOUCH SCREEN COMPUTER.........................................19
4.3. PRE-TREATMENT CONSIDERATIONS ..............................................35
4.4. PRE-TREATMENT PREPARATIONS ..................................................36
4.5. SKIN PHOTO REJUVENATION ........................................................40
4.6. HAIR REMOVAL ............................................................................47
4.7. ACNE TREATMENT ........................................................................55
4.8. PSORIASIS TREATMENT ................................................................60
4.9. SKIN TIGHTENING .........................................................................66
5. MAINTENANCE
71
5.1. CLEANING INSTRUCTIONS .............................................................71
5.2. PARTS & ATTACHMENTS ...............................................................73
6. ADVERSE EVENTS REPORT FORM
75
7. TROUBLESHOOTING
78
8. MISTRAL SERVICE
79
9. WARRANTY
80
iii
List of Figures
Figure 1: Mistral Main System......................................................................2
Figure 2: Front Panel ...................................................................................3
Figure 3: Back Panel....................................................................................3
Figure 4: Right Side Panel ...........................................................................4
Figure 5: Handpiece.....................................................................................4
Table 1: Handpiece Color Identification........................................................5
Figure 6: Footswitch.....................................................................................5
Table 2: Technical Specifications .................................................................6
Table 3: International Standards Labels .......................................................9
Table 4:
Additional Labels ...........................................................11
Figure 7: Handpiece Connection ................................................................16
Figure 8 - Pulse Counters ..........................................................................19
Figure 9: Password Entry ...........................................................................20
Figure 10: Home Page ...............................................................................21
Figure 11: Tutorial/Help Page ....................................................................21
Figure 12: Settings Page............................................................................22
Figure 13: Test Mode 1 ..............................................................................25
Figure 14: Test Mode 2 ..............................................................................25
Figure 15: Test Mode 3 ..............................................................................26
Figure 16: Test Mode 4 ..............................................................................26
Figure 17: DT Select Application ................................................................27
Figure 18: DT Treatment Page...................................................................27
Figure 19: HR DT Treatment Page.............................................................29
Figure 20: DB Patient Search.....................................................................30
Figure 21: DB Patient Details .....................................................................30
Figure 22: DB Clinical History ....................................................................31
Figure 23: DB Treatment Log.....................................................................31
Figure 24: DB Edit Record .........................................................................32
Figure 25: DB Select Application................................................................33
Table 5: Data Base Application Selection...................................................33
iv
Figure 26: DB Treatment Mode ..................................................................34
Figure 27: DB Save Treatment Data ..........................................................35
Table 6: Energy Level Setting - SR ............................................................42
Table 7: Required Results for Appropriate Energy Setting .........................43
Table 8: Energy Level Setting - HR ............................................................49
Table 9: Treatment Course Recommendations ..........................................53
Table 10: Energy Level Setting - AC ..........................................................57
Figure 28: Plaque Psoriasis .......................................................................61
Table 11: Energy Level Setting - PSOR .....................................................64
Table 12: Energy Level Setting - ST...........................................................67
Figure 29....................................................................................................71
Figure 30....................................................................................................72
Figure 31....................................................................................................72
Figure 32....................................................................................................72
Figure 33: Area Adaptor .............................................................................73
Figure 34: Fuse Location............................................................................74
List of Tables
Table 1: Handpiece Color Identification........................................................5
Table 2: Technical Specifications .................................................................6
Table 3: International Standards Labels .......................................................9
Table 4:
Additional Labels ...........................................................11
Table 5: Data Base Application Selection...................................................33
Table 6: Energy Level Setting - SR ............................................................42
Table 7: Required Results for Appropriate Energy Setting .........................43
Table 8: Energy Level Setting - HR ............................................................49
Table 9: Treatment Course Recommendations ..........................................53
Table 10: Energy Level Setting - AC ..........................................................57
Table 11: Energy Level Setting - PSOR .....................................................64
Table 12: Energy Level Setting - ST...........................................................67
v
1.
INTRODUCTION TO THE SYSTEM
Mistral is a Light and Heat Energy (LHE®) based multi-application
device for the treatment of:
•
Hair Removal (HR)
•
Skin Photo Rejuvenation (SR) (skin texture, fine lines)
•
Pigmented lesions (sun spots, age spots)
•
Vascular lesions (telangiectasias, spider veins)
•
Acne Clearance (AC)
•
Psoriasis Care (PSOR)
•
Skin Tightening (ST)
Mistral consists of a console, a Footswitch, and up to 8
interchangeable Handpieces. Each Handpiece contains a pulse
switch, a ready indicator light and an application specific lamp. The
Handpiece is held by the operator and placed directly upon the
treatment area. In this manual, the term operator applies to all qualified
personnel trained to operate the Mistral system.
Important Note – The Mistral user manual is meant as a starting point
for treatment, a reference guide of general recommendations. As you
gain more experience with the device, you may use your personal
expertise to better individualize treatment parameters.
Mistral User Manual
1
2.
SYSTEM DESCRIPTION
This chapter provides a detailed description of the Mistral system; its
main components, controls, and technical specifications. Please
review this material to familiarize yourself with controls, ports and
connectors, as well as the consumable items used during treatment.
2.1.
System Components and Controls:
The Mistral system consists of the following main components
(Figure 1):
• System console (main unit)
• Interchangeable handpieces
• Footswitch
Handpieces
Console
Figure 1: Mistral Main System
2
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CHAPTER 2
2.1.1.
Main Unit (System Console)
The main unit controls the operation of the entire system.
Front Panel:
The front panel includes:
•
•
•
•
Computer Interface / LCD Touch Screen
USB Ports
On/Off Switch
Emergency Stop Switch
Emergency Stop Button
LCD Touchscreen
USB Ports
Power Switch
Figure 2: Front Panel
Back Panel:
• Power inlet
• Main power switch
• Fuse drawer
• Handpiece cradle
• Footswith port
• System fan
• Air exhaust port
System Fan
Handpiece Cradle
Power Switch
Air Exhaust Port
Fuse Drawer
Figure 3: Back Panel
Power Inlet
Mistral User Manual
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SYSTEM DESCRIPTION
Right Side Panel:
• The Handpiece power and air connections.
Connected Handpiece
Handpiece Connections
Figure 4: Right Side Panel
2.1.2.
Handpieces
The Handpieces are connected to the main unit by a spiral cable
containing electrical wiring and an air suction hose. The Handpiece
consists of an application specific lamp, pulse switch and pulse
counter. When not in use, the Handpiece should be stored in its
cradle on the right side of the main unit. The main unit will
automatically detect the type of handpieces attached to the unit and
configure itself to conform to the attached handpiececes.
Warning: Always make sure the handpiece is secure. Do not
Pulse Switch
drop. This may cause damage to the lamp and handpiece.
Green Ready
Indicator Lights
Pulse Switch
LHE Lamp
Figure 5: Handpiece
4
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CHAPTER 2
Each handpiece is color coded for easy identifications. Please refer
to Table 1.
Table 1: Handpiece Color Identification
Handpiece
Color
Hair Removal
Hair Removal V-VI
Hair Removal (XL Spot Size)
Hair Removal V-VI (XL Spot Size)
Skin Photo Rejuvenation
Acne Clearance
Psoriasis Care
Skin Tightening
When handpieces are not in use or attached to the device,
store them in their cases to prevent damage.
2.1.3.
Footswitch
The footswitch arrives connected to the main unit. The system will
emit a pulse only if the footswitch and handpiece buttons are
pressed simultaneously.
Figure 6: Footswitch
Mistral User Manual
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SYSTEM DESCRIPTION
2.1.4.
Technical Information
Table 2: Technical Specifications
Technical Specifications
Light Source
Light & Heat Energy (LHE)
Wavelength Range
Hair Removal
400-1200 nm
Hair Removal V-VI (optional)
550-1200 nm
Skin Photo Rejuvenation
400-1200 nm
Acne Clearance (optional)
430-1100 nm
Psoriasis Care (optional)
350-1100 nm
Skin Tightening (optional)
780-1800 nm
Fluence
4-25 J/cm
Pulse Duration
Up to 45 sec
2
Spot Size
Basic
25 x 50 mm
Adaptor Sizes
13 x 50 mm
13 x 35 mm
13 x 12 mm
XL HR (optional)
35 x 50 mm
Pulse Generation Method
Capacitor bank electrical discharge switch
Physical Dimensions
40 x 47 x 32 cm (w/d/h)
15.8 x 18.5 x 12.6 in. (w/d/h)
16.8 kg./37 lbs.
Single phase 100-120 VAC ±10%, 10A, 50-60 Hz
Single phase 220-240 VAC ±10%, 8A, 50-60 Hz
Weight
Electrical Requirements
Operation Conditions
Temperature
5º-30º C
Humidity
30%-80% RH
Transport & Storage
6
Temperature
-20º- 80º C
Humidity
0%-95% RH; 0.1-1.5 atm.
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CHAPTER 2
2.1.5.
Safety Features
Many of the Mistral features were built-in to help insure the safety of
the user and patient. The following are a few examples:
•
“Ready” indicator lights on the console and handpiece
advise the user when the system is charging or ready to
emit a pulse.
•
Emergency Stop Button
•
The Footswitch prevents accidental pulses.
•
An internal and independent safety electronic circuit shuts
down pulse flashing ability in the event of a disabled blower.
2.2.
Major Precautions & Warnings
2.2.1.
•
Precautions
Verify that Mistral's nominal voltage (see label at the bottom
of the system console) conforms to the electrical voltage of
your electrical outlet. Make sure that the electrical outlet has
proper grounding.
•
Do not open Mistral’s outer case as dangerous voltages are
present inside the system. Only Radiancy certified personnel
are authorized to perform service within the protective
covers of Mistral.
•
To perform routine maintenance always shut down the
system, disconnect power and wait a minimum of 5 minutes.
Performing maintenance procedures while the system is
connected, or less than 5 minutes from disconnection may
be hazardous to the operator and destructive to the system.
•
Never use any flammable substance such as acetone or
alcohol on the skin prior to treatment.
Mistral User Manual
7
SYSTEM DESCRIPTION
•
Never use flammable substances or harsh chemicals to
clean or disinfect any part of the Mistral system.
•
Always make sure to completely lift the Handpiece off the
patient’s skin between pulses in order to avoid excessive
heating of the handpiece or skin.
•
When the Handpiece is replaced, repeat testing procedures
for each patient during the first 500 pulses.
2.2.2.
•
Warnings
Verify that all safety measures are working properly to
ensure proper safety.
•
Delivering excessive energy to the treatment site may cause
thermal damage to the skin, resulting in burns, crusting, or
abnormal pigmentation.
•
As a safety precaution, always have a first aid kit equipped
to treat burns at your disposal.
•
Operator should wear safety goggles when operating the
device.
•
Although Mistral is considered an “eye-safe” device when
operated according to instructions, supplying patients with
protective eyewear during facial treatment will provide extra
protection against discomfort from light exposure.
•
Never look directly at the light coming from the handpiece as
this may cause temporary eye discomfort.
•
The ST application emits infrared light which is invisible to
the naked eye. Do not allow the lamp to emit a pulse into
free-space or look into it as it is emitting a pulse sequence.
•
8
Looking away during the flash will further prevent discomfort.
Revision 07, August 2009
CHAPTER 2
•
Never allow the Handpiece to emit a pulse into ‘free space’.
Always make sure that the Handpiece is pointed at and in
full contact with the skin during treatment.
•
Even when the Energy level on touch screen is set at “0”,
the system can still trigger a pulse. Therefore be aware of
the position of the Handpiece at all times to avoid accidental
flashing.
•
Always remain in visual contact with the computer screen to
ensure that the established energy is the correct "working
energy" setting.
•
Pigmented moles and beauty spots and any suspicious
(abnormal) pigmented lesion should be covered with a nonflammable white sticker.
2.2.3.
Labels
This section describes the labels affixed to Mistral. It is
recommended that users review the meaning of these labels for
everyday use and in case any details are needed for service.
The table below briefly reviews a number of the internationally
recognized symbols that are found on the Mistral main unit and its
external package.
Table 3: International Standards Labels
Symbol
Meaning
Comments
Attention, consult
accompanying documents
before use
Attention, consult
accompanying documents
before use
Mistral User Manual
9
SYSTEM DESCRIPTION
Manufacturer
Authorized representitive in the
European community
Degree of protection against
electric shock: Type BF applied
part
CE mark represents the
compliance to the European
Medical Device Directive
93/42/EEC, Class IIa device.
The number (0344) is of the
notifying body, KEMA Notified
Body.
Protect the environment by not
disposing of this product with
household waste (2002/96/E).
Check your local authority for
recycling advice and facilities
(Europe only).
Voltage sticker
Appears on outer
package
The C-Tick mark represents
compliance to Australian EMC
Regulations.
Additional stickers found on the main unit and the handpieces include serial
numbers of system parts and usage warnings.
10
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CHAPTER 2
Table 4: Additional Labels
Label
Location and Comments
Located on the back of the system this
label includes manufacturer details, voltage
information, and the system’s serial
number.
Located on Mistral Handpieces
HR Handpieces:
Basic and optional XL
HR V-VI Handpiece (optional): Basic and
XL
SR Handpiece
AC Handpiece (optional)
PSOR Handpiece (optional)
ST Handpiece (optional)
On rear panel, above power inlet. On 100120V systems, and on 220-240V systems,
respectively.
Mistral User Manual
11
SYSTEM DESCRIPTION
Label
Location and Comments
On rear panel.
This warning appears on all handpiecess,
next to opening.
12
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CHAPTER 2
2.2.4.
International Standards Compliance
The Mistral complies with the following international standards and
directives:
EMC Standards:
IEC 60601-1-2:2001 + A1:2004
Clause 36.201 (Emission);
Clause 36.202 (Immunity);
Harmonized Standards:
Medical Electrical Equipment – Part 1:
General Requirements for Safety:
IEC60601-1:1988 + A1:1991 + A2: 1995
EU Directives:
- Low Voltage Directive 2006/95/EC
- Electromagnetic Compatibility Directive
2004/108/EC
- Medical Device Directive 93/42/EEC –
Class IIa device marked as CE 0344 of the KEMA Notified Body
(only for the Acne Clearance and Psoriasis Care applications)
Mistral User Manual
13
3.
INITIAL SET UP
3.1.
Unpacking Mistral
The Mistral system is supplied with the following components:
•
Main Unit (console)
•
1 HR Standard Handpiece
•
1 SR Standard Handpiece
•
Optional Handpieces
•
ST Handpiece
•
AC Handpiece
•
PSOR Handpiece
•
HR XL Handpiece
•
HR Sensitive Handpiece
•
HR Sensitive XL Handpiece
•
Client Safety Goggles
•
3 Area Adaptors
•
2 Packs of Hygienic Rings (10 hygienic rings per pack)
•
Footswitch
•
Power Cable
•
User Manual
•
2 Fuses
•
Treatment Coat
•
Touch Screen Stylus
3.2.
Electrical Requirements
Before unpacking Mistral, make sure the work site meets the
following electrical requirements. Mistral requires a separate single
phase supply line with nominal voltage (according to the local line
voltage):
•
14
Single phase 100-120 VAC ±10%, 10A, 50-60 Hz; or
Revision 07, August 2009
INITIAL SET UP
•
Single phase 220-240 VAC ±10%, 8A, 50-60 Hz
Mistral is grounded via the grounding conductor in the power cable
that is plugged into the wall power outlet. Good grounding is
essential for safe operation of the device.
It is recommended that the system’s power cable not be placed on
the same circuit as devices with heavy variable loads, such as air
conditioning units. The fuses located within the unit are rated:
•
5x20T, 250V 10A for 100-120VAC and
•
5X20T, 250V 8A for 220-240 VAC.
Be sure to use the appropriate fuse for your region's electrical
requirements. When a fault in the system occurs, the fuse will burn
out and the system will not run.
3.3.
Installation
Mistral is designed for easy installation and does not require any site
preparation. Installation is carried out as follows:
♦ Unpack the system and place it in a designated location.
It should be placed on a flat, stable surface, such as
table, counter or sturdy cart.
♦ Verify that the system is intact and that all its components
are present.
♦ Verify that the nominal voltage, recorded on the
underside of the unit, conforms to the electrical voltage of
your country (100-120V/220-240V).
3.3.1.
Handpiece Connection
If necessary, connect the Handpiece according to the following
instructions (Figure 7):
a. Align the Handpiece power and air connectors with
its power outlet and air suction inlet. Use the metal
prongs as a guide.
b. Snap into place.
Mistral User Manual
15
CHAPTER 3
Figure 7: Handpiece Connection
To remove handpiece:
a. Push button on back of connector
b. Gently pull and pop out connection.
Note: Turn the system off when replacing or exchanging handpieces.
After the handpiece/s are connected:
•
•
Plug the system into a designated
electrical outlet.
Test the system for proper operation.
Again, always make sure the handpiece is secure. Do not drop. This
may cause damage to the lamp and handpiece.
16
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4.
OPERATION AND TREATMENT PROTOCOLS
4.1.
General Guidelines for the Operation of Mistral
The general guidelines below are relevant for all Mistral applications.
To insure patient safety, attain optimal clinical results and protect
device performance, operators should adhere to the following
protocols:
1.
Activation – To turn the system on; toggle the power switch on the
back of the unit to the on position. Then press the On/Off button
located on the front of the system. You will be directed to the
introductory screen.
2.
Choosing Treatment Mode – Mistral automatically detects from the
connected handpiece the proper treatment mode. Make sure the
handpiece/s you have connected are appropriate to the application/s
you will be treating.
3.
Test Energy Levels – Always use the test energy settings defined in
the application specific tables as a starting point.
4.
Proper Handpiece Positioning – Always position the Handpiece in
full contact with the skin with minimal to no overlapping. After the
pulse is administered, immediately and completely remove the
handpiece from the skin.
5.
Pulse Generation –When the “Ready” indicator is activated on the
LCD screen and Handpiece, trigger the pulse by pressing the
footswitch then the pulse switch.
6.
Between Pulses – Remove the handpiece copmpletely away from
the skin.
WARNING
To avoid eye discomfort, never look directly at the light
coming from the Handpiece.
Mistral User Manual
17
CHAPTER 4
7.
Overlapping – No overlapping is necessary. If unavoidable, keep
overlapping to a minimum of 5%. Stacking and/or excessive
overlapping can cause crusting or blisters which can lead to transient
pigmentary changes.
8.
Additional Pulses – To trigger the next pulse, wait until charging is
completed and the “Ready” indicator is activated again. Place the
Handpiece on the treatment spot and repeat.
9.
Area Adaptors – The Area Adapters should be used when treating
small or narrow areas. No energy level adjustments are necessary
when using the small area adaptors.
10. New Handpiece Retest – Each time an old Handpiece is replaced
with a new one, the testing procedure for all existing patients should
be repeated for the first 500 pulses. The system recognizes when a
handpiece is first used and will automatically direct the operator to
the appropriate testing screen.
11. Excessive Energy Level – Stop treatment if overall redness of the
treated area is observed. Full redness of the area may indicate use
of an excessive energy level. It is recommended to treat with
caution, especially during the initial treatment.
12. Post Treatment – Mild redness and regional pain may be noticed in
the treatment area and can last from a few hours up to a few days.
Most patients will feel some discomfort for up to an hour or two after
treatment. A post treatment preparation (e.g., Biafine or Aloe) can be
used to help soothe the area but should not be used on skin with
open wounds. Cold packs alternantly applied for 10-15 minutes on
the affected area are another post treatment option. If blistering or
burns occur, aggressive wound treatment should be administered.
If skin crusting occurs, do not continue treatment until the crusting has
resolved and completely healed.
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OPERATION AND TREATMENT PROTOCOLS
13. Sun Exposure – The patient should be advised to avoid sun
exposure and/or artificial tanning devices for a minimum of 21 days
before and after treatment. If hypo or hyper pigmentation occurs, the
patient should continue to be diligent about sun or light exposure
until it resolves. Pigmentary changes generally resolve within a few
months and may be treated with daily application of sunscreen and
bleaching creams.
14. Emergency Stop Button – When it is necessary to immediately stop
treatment, push the red Emergency Stop button located on top of the
system.
15. Pulse Counter – Counts the total number of delivered pulses for that
treatment. (Figure 8)
16. Total Handpiece Pulses – Counts the total number of delivered
pulses from that handpiece. You will receive alerts when the pulses
approach and/or exceed the maximum pulse allowance. (Figure 8)
Treatment
Pulse Counter
Handpiece
Pulse Counter
Figure 8 - Pulse Counters
4.2.
Using the Touch Screen Computer
Mistral's touch screen is designed to guide you through the entire treatment
process. It is recommended to read this section carefully and to completely
Mistral User Manual
19
CHAPTER 4
familiarize yourself with the computer interface before beginning treatment.
You may use the stylus or your finger to gently tap and activate the touch
screen pad. Using the stylus is recommended.
When treating patients, the operator may choose either direct or data base
treatment protocols. For instance, this may be a one time procedure and there
will be no need to save the information. Or, the patient may be returning for
repeat sessions and having patient history will streamline future treatment
sessions. This section will describe both forms of treatment protocols.
4.2.1.
System Startup
1. After inititating start-up,the system will automatically begin with a short
introductory loading page.
2. When the introduction is finished the user will be automatically directed
to the logon screen. Using the numbers on the LCD screen, enter your
password and press enter. (Figure 9)
Enter Password Here
Backspace
Enter Key
Turn Off System
Figure 9: Password Entry
3. You will be directed to the Home Page (Figure 10). On the home page
you may navigate to training, personalize your settings or choose the
20
Revision 07, August 2009
OPERATION AND TREATMENT PROTOCOLS
mode of treatment. Gently tap the screen where you wish to go next.
Figure 10: Home Page
4. Training (Figure 11) - The tutorial page allows access to a Mistral
training video and the help file.
Figure 11: Tutorial/Help Page
5. Settings (Figure 12) – For first time users, it is recommended to set the
language preference and system parameters before beginning the first
treatment.
Mistral User Manual
21
CHAPTER 4
Figure 12: Settings Page
a. Export/Import Data Base – using the USB ports found on the
front bottom right of Mistral, you may export or import either
data base or treatment files from or to an outside source.
b. Screen Calibration – Calibration should be performed once
every 6 months.
i. Carefully press or touch stylus on center point of target.
Using the stylus for calibration is highly recommended.
ii. Hold in place until target moves.
iii. Follow the target around the screen until calibration is
complete.
iv. After calibration, tap the screen once to save data or
wait 30 seconds to keep old data. You will be
automatically directed to the settings page.
c. Technical Information – This section is password protected and
only accessible by a certified technician.
6. Once your settings have been entered, they will be automatically
saved and available the next time you use the system. Select "Exit" to
return to the home page.
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OPERATION AND TREATMENT PROTOCOLS
4.2.2.
Test Mode
Before beginning any treatment, each patient should be tested to determine
the safest and most effective treatment parameters. When testing in the Data
Base mode, all results will be saved and added to the patients profile. When
testing in the Direct Treatment mode, results will not be saved and should be
noted for that treatment only.
1. To access Test Mode from Direct Treatment
a. Select Direct Treatment > select Application > select Test
Mode
2. To access test Mode from Data Base Treatment
a. Select Data Base Treatment (new patient)> select new patient
and enter patient details> select Application > select Test
Mode.
b. Select Data Base Treatment (previous patient)> select patient
> select Application > select Test Mode.
After entering Test Mode(Figure 13 and 14), an orange frame will blink around
the buttons to guide you through each step. Simply follow it as you make your
selections.
a. Select between Caucasian and Asian Skin Type.
b. Select Skin Type.
c. Press the first pulse button when it starts to blink.
d. Confirm the preset energy level by selecting the green
checkmark. Further fine tuning can be done by the arrows on
both sides of the energy level.
i. The energy level is confirmed when the checkmark is
replaced by a small orange sun.
e. Trigger the first pulse on the tested area. Apply the pulse by
pressing on the footswitch followed by simultaneously pressing
the handpiece pulse button. The pulse will not trigger unless
the footswitch is depresssed.
f.
Lift the handpiece completely away from direct contact with the
skin between pulses.
Mistral User Manual
23
CHAPTER 4
g. Release footswitch between pulses.
h. The next sequence begins after the pulse has been emitted.
i.
Repeat steps d-f for the second and third pulse.
j.
Place test pulses next to each other to aid in comparison and
observation.
k. The proper setting is the test area that produced the required
result according to treatment application. Refer to the section of
the user manual that explains these parameters.
l.
If further adjustments are necessary to achieve the required
results, they should be applied at the next session to insure
that no adverse effects are reported.
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OPERATION AND TREATMENT PROTOCOLS
Data Base Treatments: After determining proper parameters, save data. The
data will be available for your next treatment session.
Verify energy level
Skin Type
Skin Photo Type
Figure 13: Test Mode 1
Figure 14: Test Mode 2
3. Direct Treatment: After testing, note results.
4. Data Base: After testing, confirm and save energy levels.(Figure 15)
Mistral User Manual
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CHAPTER 4
Figure 15: Test Mode 3
5. If the test session must be cancelled early, you have the option to save
results already obtained.
Figure 16: Test Mode 4
4.2.3.
Direct Treatment
1. Select application. Only applications that are related to the attached
handpieces will be accessible, all other applications will be greyed out.
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OPERATION AND TREATMENT PROTOCOLS
Non-activated
treatment mode
Activated
Treatment mode
Figure 17: DT Select Application
2. After determining proper treament parameters, return to treatment
mode and begin treatments.
a. Enter energy level: use arrows or number pad
b. Confirm choice; after confirming choice, the green check mark
will be replaced by an orange sun.
c. Apply pulse: wait for the audible ready signal, press the foot
switch then the one of the handpiece pulse switches.
d. Continue treatment using determined protocols from the
section of the user manual relevant to the application being
used.
Set Energy Level here
Confirmed Energy Level
Confirm Choice here
Return to Home Page
Mute Button
Figure 18: DT Treatment Page
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3. Optimal Pulse Train (OPT) Settings
OPT is used during HR and ST treatments.
During hair removal, OPT takes advantage of the skin's thermal
relaxation time. A pulse train of 3 short bursts with 2 rest periods is
delivered. The rest period is optimized to the skin type's thermal
relaxation time, allowing the skin to cool as heat is built up inside the
follicle, bringing it comfortably to the coagulation point.
A similar process occurs during skin tightening. As the deeper layers of
the dermis reach optimal treatment temperature, OPT technology
keeps the outer layers of the skin cool and safe.
Hair Removal and Skin Tightening treatments should follow the
following protocol:
a. Select OPT pulse pattern. The default is the medium pulse
width and testing should always begin there. If the results are
below unsatisfactory and there is no pain, select the short
pulse width. If the patient experience discomfort or pain, select
the long pulse width. After the initial pulse, you may use the
guide below to help determine the OPT pattern to use. Refer to
Table 8 for HR and Table 12 for ST for initital pulse width and
energy settings.
b. Enter energy level: use arrows or number pad
c. Confirm choice; after confirming choice, the green check mark
will be replaced by an orange sun.
d. Apply pulse: wait for the audible ready signal, press the foot
switch then the one of the handpiece pulse switches.
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OPERATION AND TREATMENT PROTOCOLS
Handpiece
Spot Size
Pulse Width
Figure 19: HR DT Treatment Page
Note: The pulse width patterns are graphically represented by short, medium
and large plateaus. When editing or entering treatment details on the patient
display, these patterns are represented numerically; 10 (short), 20 (medium)
and 30 (large).
Note: All other treatment modes use the same protocols as mentioned above.
4.2.4.
Data Base Treatments
The Keyboard
o
The keyboard has 3 modes, upper case letters, lower case
letters and numeric. The standard keyboard contains all lower
case letters and a limited number of commonly used
characters. The upper case keyboard includes all upper case
letters and a limited number of commonly used characters. The
numeric keyboard includes all numbers and other commonly
used characters not visible on the standard keyboard.
o
To toggle between them, tap the
or
key once. This will
allow you to enter 1 number or character.
o
To keep the keyboard visible, tap the
or
o
To return to the standard keyboard, tap the
key twice.
or
key once.
1. From the Home Page, select Data Base Treatment.
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2. From this page, you may search for previously entered patients or
create a new profile. (Figure 20)
3. Patient Search – Mistral uses a 'smart search' system to help find your
patient quickly and easily. Enter the first few letters or digits into one of
the search fields. Once you have found your patient, select 'Patient
Details' to bring up their data base.
Patient Search Fields
Figure 20: DB Patient Search
1. To enter a new patient, select New Patient from the patient search
page. (Figure 20) Enter patient details using the LCD keyboard.
(Figure 21)
Figure 21: DB Patient Details
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OPERATION AND TREATMENT PROTOCOLS
2. Enter all relevant pre-treatment clinical history (Figure 22).
Figure 22: DB Clinical History
Side Effects: This refers to any side effects your patient may
have experienced with other devices or treatments prior to
using Mistral.
• Pigmentation: This refers to the degree of any previous
pigmentation changes that your patient may have experienced
with other devices or treatments prior to using Mistral.
• History: This refers to your patients medical history prior to
using Mistral.
3. Treatment details will be automatically saved and recorded under
•
patient history. (Figure 23)
Figure 23: DB Treatment Log
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4. To edit a patient's profile, select Edit Record and change any details
as needed. From here you may save changes or remove the patient
completely from your data base.
Caution: Any changes made to the patients record are permanent.
No history will be saved. Be certain of changes before
implementing them. It is recommended to save hard copies of all
patient files and details.
Figure 24: DB Edit Record
5. Select your application. A drop down menu will appear to give you a
more focused treatment selection. All treatment details will be saved to
the data base.
6. Only applications that are related to the attached handpieces will be
accessible, all other applications will be greyed out.
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OPERATION AND TREATMENT PROTOCOLS
Figure 25: DB Select Application
7. Each application has a drop-down menu for a more focused treatment
target. The treatment area will be saved to the data base. Refer to the
table below for complete treatment area selection options.
Table 5: Data Base Application Selection
Hair Removal
Skin Photo Rejuvenation
Acne Clearance
Psoriasis Care
Skin Tightening
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8. For repeat clients, you will be automatically directed to the treatment
mode with all the details from the last treatment. You will be able to
immediately begin treatment. (Figure 26)
9. When treating your patients, especially for first time, confirm patient
details with the treatment log.
10. To switch applications, press the select application button and you will
be directed once again to the Data Base application selection page.
(Figure 25)
Figure 26: DB Treatment Mode
11. Administer Treatment
a. Use the preprogramemd energy level or adjust using the
arrows or number pad
b. Confirm choice; after confirming choice, the green check mark
will be replaced by an orange sun.
c. Apply pulse: wait for the audible ready signal, press the foot
switch then the one of the handpiece pulse switches.
d. Continue treatment using determined protocols from the
section of the user manual relevant to the application being
used.
12. At the end of each session, you will be prompted to save treatment
details.
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OPERATION AND TREATMENT PROTOCOLS
Figure 27: DB Save Treatment Data
13. Select "Select Application" to administer another type of treatment to
your patient.
14. Return to the home page to begin treatment on a new patient.
4.3.
Pre-Treatment Considerations
During the first visit examine the areas intended for treatment,
take patient medical history, and determine skin photo type and
sensitivity.
A complete patient history should be given and
include all information regarding previous treatments for the same
condition, previous hair removal habits and any information as to
whether the patient is; easily irritated by shaving, has had any
reactions to waxing or if their skin is generally sensitive to creams
and lotions.
It is also necessary to determine if the patient has a history of
keloids or hypertrophic scarring. Patients with a history of these
conditions should be treated less aggressively.
Thoroughly explain to the patient the treatment procedure,
expected results, possibility of potential side effects, and the
importance of completing a full treatment course. Advise the
patient that there may be some discomfort, erythema, edema or
blistering associated with the treatment and that there is a minimal
Mistral User Manual
35
CHAPTER 4
risk of adverse side effects such as changes in texture, and hypo
or hyperpigmentation. Adverse effects, should they occur, are
usually transient and should resolve themselves within a few
months.
In case any serious side effects occur, refer to Adverse Effects
Report (6). If the effects match any of the criteria found there,
copy then fill out the form and send it by FAX or email to your
Radiancy Distributor and to Radiancy Ltd. within 48 hours of
noticing the effects.
Topical or general anesthesia is not required. Should the patient
feel discomfort, however, it may be recommended (e.g.: EMLA,
Elamax, Topicaine). If a topical anesthesia is applied, carefully
follow the instructions found in chapter 4.4.4.
4.4.
Pre-Treatment Preparations
4.4.1.
•
Prior to Treatment:
Have the patient sign an Informed Consent Form (ICF)
indicating that they consent and agree to the treatment
and that they understand and agree to the procedure and
its potential side effects.
o
It is very important to keep on file a hard copy of all
patient
records,
including
pre-treatment
photographs.
•
Thoroughly clean the area to degrease the skin and
remove any remains of cream, makeup, or topical
anesthesia. Do not use any flammable solutions, such as
alcohol or acetone to clean the treatment area.
•
Ensure that the skin surface is completely dry.
•
Cover moles and pigmented spots with non-flammable
white sticker or sceptic pencil.
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OPERATION AND TREATMENT PROTOCOLS
•
When treating the face
Draw back the hair and cover it.
Provide protective eyewear for client.
o
o
WARNING
Pigmented moles and beauty spots should be covered with a
white sticker. Do not use flammable material.
4.4.2.
Determining the Patient’s Skin Type
To evaluate patient’s skin type, use the Fitzpatrick Skin Type
Classification scale found below. Take into consideration whether
or not the patient heals darker in the area of an injury or scratch or
whether they have a history of keloids or hypertrophic scarring.
This can reveal a potential for pigmentary changes.
Also, keep in mind that the patient's skin tone may appear darker
during the summer when there is greater sun exposure. If there is
any doubt regarding actual skin photo type, always treat the
patient according to the higher option. For example, if there is a
question as to whether a patient is skin Type III or IV treat them
as a Type IV and set the energy level to the appropriate level for
the application you are using. Then gradually increase energy
levels as necessary.
FITZPATRICK SKIN TYPE CLASSIFICATION
I
Always burns, never tans
II
Always burns, tans less than average
III Sometimes burns, tans average
IV Rarely burns, tans with ease
V
Moderately pigmented, always tans
VI Deeply pigmented, never burns
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4.4.3.
Pre-Treatment Test
Caution:
•
As some patients may have a delayed reaction to the light
flash, do not perform more than 3 test pulses during the
first test session. Wait at least 24 hours before
administering the first treatment.
•
For patients with Fitzpatrick Skin Types IV-VI, it is
recommended to wait at least 48 hours to evaluate test
results.
The purpose of testing is to get to know the patient’s individual
skin, to understand its sensitivities and special differences and to
establish the pulse energy level for the patient's first complete
session.
Optimal energy level settings differ from patient to patient, from
skin type to skin type, from treatment area to treatment area and
from application to application. Therefore, for each of the
procedures listed below, the energy level should be optimized for
that application according to both the individual patient and the
specific area being treated.
The energy levels in the test tables are intentionally conservative
and are meant as a starting point. Refer to the appropriate table
under each application for your initial settings. From this starting
point, you should be able to pin-point the highest and safest
energy level for your patient. Stay in constant verbal contact with
your patient to learn exactly how the treatment is affecting them,
what they are feeling and if they are comfortable. This will help
you decide whether or not to use a higher energy level.
It is important to take into consideration what you learn about the
patient's skin during the pre-treatment test to determine how to
best proceed with the treatment and to aid in attaining optimal
settings and results for each individual patient.
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OPERATION AND TREATMENT PROTOCOLS
4.4.4.
Using Topical Anesthesia
Note and follow the manufacturer's instructions,
contraindications and warnings.
Topical anesthesia (e.g.: EMLA, L.M.X.4, Topicaine) may be applied
prior to treatment for patients who might feel discomfort during
treatment.
Apply as follows:
•
At least one hour prior to treatment, apply the topical
anesthesia directly onto the skin.The total effect time is
3 hours. However after 2 hours it begins to lose peak
effectiveness.
•
Apply liberally, but do not rub it into the skin.
•
Cover with an occlusive (adhesive, clear plastic or
nylon) dressing.
•
Immediately before treatment (at least 60 minutes after
it has been applied), remove the dressing. Using a
damp cloth or hygenic wipe, remove any residual
anesthesia., then thouroughly clean and dry the entire
area before begining any procedure.
The above are general guidelines. With any specific topical
anesthesia, always follow the manufacturer's instructions.
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CHAPTER 4
4.5.
Skin Photo Rejuvenation
Warning: Make sure you have the proper handpiece for SR treaments
4.5.1.
Indications
Mistral SR treatments are indicated for patients in good general health,
18 years of age or older, who suffer from the following skin conditions:
•
Pigmented lesions related to sun damage and aging
•
Superficial vascular lesions
•
Erythema related to rosacea
•
Fine lines and wrinkles (rhytides)
•
Skin aging in the form of overall tone and texture
Mistral may be used to treat the face, neck, décolleté, arms and
the back of hands.
4.5.2.
Contraindications
Mistral should not be used on patients who:
• Are pregnant or lactating.
• Have tanned by sun or artificial tanning machine within the last
21 days.
• Have a tattoo or permanent makeup in the treatment area.
• Have abnormal skin conditions due to differnet diseases,
conditions (e.g. diabetes) or medicinal intake.
• Have a history of local skin infections.
• Have been treated with isotretinoin (Accutane) within the past
6 months.
• Have used any medications, herbal preparations or chemicals
that cause photosensitivity, within the past 6 weeks. These
include but are not limited to gold therapy, tetracycline or sulfa
drugs,
40
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Revision 07, August 2009
certain
psychiatric
medications.
OPERATION AND TREATMENT PROTOCOLS
In case of uncertainty regarding photosensitizing side-effects,
have the patient consult their physician.
• Suffer from epilepsy.
• Have diseases related to photosensitivity, such as Porphyria,
Polymorphic Light Eruption, Solar Urticaria, Lupus and other
autoimmune diseases.
• Have a history of herpes outbreaks in the treatment area,
unless the patient has consulted their physician and received
prophylaxis treatment prior to treatment.
• Have a history of skin cancer or patients who have areas of
potential skin malignancies.
•
Have received chemotherapy or radiotherapy treatments within
the past 5 years should not be treated without their acting
physician's consent.
• Have been on a steroid regimen (i.e. for asthma) over the last
3 months.
• Have an active implant, such as a pacemaker, incontinence
device, insulin pump, etc.
• Have any other condition which in the practitioner’s opinion
would make it unsafe for them to be treated.
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4.5.3.
Pre-Treatment Test –
Skin Rejuvenation Applications
Table 6: Energy Level Setting - SR
I
II
III
IV
V
VI
55
50
40
20
10
0
Pulse
65
60
50
25
18
10
3 Pulse
75
70
60
30
25
18
st
1 Pulse
2
nd
rd
Set the energy level for the first pulse according to the table above.
For example, if the patient has skin Type III, the energy level for the
first test pulse should be set at 40. Next, refer to Table 7 for the
required reaction. If the required reaction in the target area is
observed, this is the appropriate energy level to begin treatment. If the
required results do not appear, increase the energy level according to
Table 6 until the required results are observed. Wait a minimum of 30
seconds between test pulses to determine the skin’s reaction.
When testing and treating a single spot, a pigmented lesion for
example, wait a minimum of 1-2 minutes before retesting the same
spot. Be careful to treat only the target areas (e.g. pigmented lesions),
and not the surrounding tissue.
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Table 7: Required Results for Appropriate Energy Setting
Application
Pigmented
Lesions
Vascular
Lesions
Fine Lines
Required Results
Adverse Reaction
If redness* or darkening of the
lesion is observed, but not
redness of the surrounding
tissue, then the energy level is
appropriate.
If the lesion becomes more
apparent, the energy level is
appropriate for treatment.
Some redness may also be
observed in the surrounding
skin, this is normal.
If mild redness appears on the
skin and quickly disappears
after the test, the energy level
is appropriate for treatment.
• Redness that lasts
more than 20 minutes
after the pulse.
• Blistering
• Burning sensation that
lasts more than an
hour or two
• Crusting of skin tissue
beyond the lesion itself
• Redness that lasts
more than 20 minutes
after the pulse.
• Blistering
• Burning sensation that
lasts more than an
hour or two
* Redness should be subtle and diffuse, not reflecting the shape of
the lamp opening.
If the required result is not observed immediately following or within 24
hours after the test, you have not yet reached the optimum level for the
treatment area. There is no need for further testing. As you begin
treatment, continue to raise the energy level by increments of 5 until
the required results are observed. This often means raising the level
above those recommended in the table.
If at any point there is an adverse reaction, lower the energy level to
the next highest level that did not cause an adverse effect. Resume
treatment only after the skin has completely healed.
4.5.4.
•
Treatment Principles: Pigmentary Lesions
(Sun Spots, Age Spots, etc.)
Before administering treatment, refer to section 4.1. Carefully
follow the guidelines presented there.
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CHAPTER 4
•
Should there be any doubt as to the nature or origin of a
pigmentary lesion or spot, have the patient consult their
dermatologist before beginning treatment.
•
Set the initial energy level according to test results. As
treatment progresses and the lesion becomes lighter in color,
you may need to use higher energy levels to maintain clinical
efficacy.
•
A full treatment course generally consists of 2-4 sessions
spaced 1-3 weeks apart. When skin crusting occurs, do not
perform further treatments until the skin has completely healed.
•
When treating a well defined pigmented spot, treat only the
spots, not the surrounding skin. The surrounding skin may be
covered with a white nonflammable sticker.
•
For proper treatment, redness or change in pigmentation color
should appear on the spot, but not the surrounding skin.
•
When using Area Adaptors, make sure to use the smallest
adaptor that completely covers the treatment area. No energy
changes are required when using adaptors.
•
Up to two (2) to four (4) crisscrossed pulses may be
administered on the same spot in each treatment session,
based on the practitioner’s best judgment. Wait a minimum of
1-2 minutes between each pulse.
•
The removal of the treated pigmented lesion does not prevent
a new one from appearing.
4.5.5.
Treatment Principles:
Vascular Lesions
Mistral may be used to treat small superficial vascular lesions, up
to 0.5 mm diameter, appearing on the face and décolleté only, not
on other areas of the body. Results are very individual and often
depend on the depth and size of the lesion.
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OPERATION AND TREATMENT PROTOCOLS
•
Before administering treatment, refer to section 4.1. Carefully
follow the guidelines presented there.
•
Set the initial energy level according to test results. Vascular
lesions tend to fade as treatment progresses. As the lesion
becomes lighter in color, you may need to use higher energy
levels to maintain clinical efficacy.
•
A full treatment course generally consists of 4-8 sessions
performed one to two times per week.
•
Evaluate the treatment's progress after 2 treatments (not
including the testing session). If the lesion or its branches start
to fade, continue treatment as before. If not, raise the energy to
the maximum level the skin will tolerate without adverse side
effects. If significant improvement is not observed within 4
treatments, consider early termination of treatment.
•
Treat only the vascular lesions themselves. Be careful to avoid
treating the surrounding skin.
•
When treated, the vascular lesion should become more
apparent along with possible redness of the surrounding skin.
•
Up to four (4) crisscrossed pulses may be administered on the
same spot in each treatment session based on the
practitioner’s best judgment. Wait a minimum of 1-2 minutes
between each pulse.
4.5.6.
•
Treatment Principles:
Skin Texture Treatment
Before administering treatment, refer to section 4.1. Carefully
follow the guidelines presented there.
•
Set the energy level according to test results.
•
A full treatment course generally consists of 5-6 sessions
spaced 2-3 weeks apart.
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CHAPTER 4
•
When treating fine lines, wrinkles, and skin texture treat the
entire face.
•
The appropriate energy level for treatment is one that causes
only mild redness and disappears quickly after the pulse.
•
Perform two passes in a crisscross pattern over the entire face.
Wait a minimum of 3-5 minutes between the passes to prevent
over heating the skin. During the second pass the handpeice
orientation should be rotated 45-90 degrees.
•
Use extra caution when treating the neck and, due to bone
proximity, the back of hands and décolleté. Lower the energy
level by 5-10 points.
•
Maintenance treatments should be performed as needed.
4.5.7.
Post Treatment Care
In addition to post treatment care described in section 4.1, advise the
patient to avoid bathing in hot water, facial peeling creams or
preparations that may irritate the skin for 24 hours following treatment.
The patient should also understand that avoiding sun exposure and
artificial tanning devices for a period of not less than one month
following treatment is particularly important for the success of skin
rejuvenation treatments.
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OPERATION AND TREATMENT PROTOCOLS
4.6.
Hair Removal
Warning: Make sure you have the proper handpiece for HR treaments
4.6.1.
Clinical Background
A clinical study was conducted on 21 patients for 18 months to assess
the efficacy, side effects and long-term results of LHE devices.
Subjects underwent 4-9 treatments, depending on the area treated,
and were followed up 3-6 months after the last treatment. Results
were:
•
Average percentage of hair reduction at completion of
treatment was 71% for males (back, chest, legs) and 80%
for females (axilla, bikini line).
•
Significant hair reduction was also observed 3-6 months
after the last treatment session in both females (71%) and
males (58%).
•
Average number of sessions for females 5.5, for males 7.5
•
Side effects were all minor and transient
4.6.2.
Indications
The Mistral HR treatment is indicated for patients in good general
health, 18 years of age or older with skin types I-VI according to the
Fitzpatrick skin type classification.
4.6.3.
Contraindications
The Mistral HR should not be used on patients who:
•
Used any method of epilation other than shaving in the
treatment area within the past 30 days.
•
Have inflammatory skin conditions or open sores.
•
Are pregnant or lactating.
Mistral User Manual
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CHAPTER 4
•
Have tanned by sun or artificial tanning machine within the last
21 days.
•
Have a tattoo or permanent makeup in the treatment area.
•
Have abnormal skin conditions due to differnet diseases,
conditions (e.g. diabetes) or medicinal intake.
•
Have a history of skin disorders such as vitiligo or psoriasis in
the treatment area.
•
Have a history of local skin infections.
•
Have been treated with isotretinoin (Accutane) within the past 6
months.
•
Have used any medications, herbal preparations or chemicals
within the past 6 weeks that cause photosensitivity.
These
include but are not limited to gold therapy, tetracycline or sulfa
drugs, and certain psychiatric medications.
In case of uncertainty regarding photosensitizing side-effects,
have the patient consult their physician.
•
Suffer from epilepsy.
•
Have diseases related to photosensitivity, such as Porphyria,
Polymorphic Light Eruption, Solar Urticaria, Lupus and other
autoimmune diseases.
•
Have a history of herpes outbreaks in the treatment area,
unless the patient has consulted their physician and received
prophylaxis treatment prior to treatment.
•
Have a history of skin cancer or patients who have areas of
potential skin malignancies.
•
Have received chemotherapy or radiotherapy treatments within
the past 5 years should not be treated without their acting
physician's consent.
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OPERATION AND TREATMENT PROTOCOLS
•
Have been on a steroid regimen (i.e., asthma) over the last 3
months.
•
Have an active implant, such as a pacemaker, incontinence
device, insulin pump, etc.
•
Have any other condition which in the practitioner’s opinion
would make it unsafe for them to be treated.
4.6.4.
Pre-Treatment Test - Hair Removal
Trimming - Prior to testing or treatment, the hair should be trimmed to
a length of 1-2 mm or shaved 3-6 days before treatment and left to regrow to the desired length of 1-2 mm. After trimming, clean dry and
cover spots as outlined in section 4.4.1. Be sure there are no
unattached hairs left on the skin surface before beginning treatment.
Pre-treatment test settings After choosing the HR application and patients skin type, the system
will be set automatically to the recommended test energy level. See
Table 8 for reference.
Table 8: Energy Level Setting - HR
I
II
III
IV
V
VI
30
25
20
10
0
0
Pulse
40
30
25
20
5
2
3 Pulse
48
40
30
25
10
5
st
1 Pulse
2
nd
rd
The appropriate energy level has been reached if any of the following
required reactions are observed immediately following the pulse:
• Darkening/burning of the hair
• Skin redness around the hair (Perifollicular erythema) immediately or within 10-15 minutes after pulsing.
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• Note for advanced users: The optimal result is achieved when
the hair in the majority of the pulse area has completely
disintegrated. If the energy level you're using provides good
results but still not optimal, you may attempt to raise the energy
level in increments of 2-5 levels with each pulse until most of
the hair in the pulse zone is disintegrated.
If you do not observe any of the required results in the test area,
increase the energy level according to the table until the required
results are achieved. Typically, it is advisable to wait a minimum of 30
seconds between each test pulse to determine the skin’s reaction.
Pulses should be applied on adjacent test spots, include test spots on
the intended treatment area.
If the required result is not observed immediately following or within 24
hours after the test, you have not yet reached the optimum level for the
treatment area. As you begin treatment, continue to raise the energy
level by increments of 5 until the required results are observed. This
may mean raising the level above those recommended in the tables. If
at any point there is an adverse reaction, lower the energy level to the
highest level that did not cause this adverse effect. Resume treatment
only after the skin has fully healed.
4.6.5.
•
Treatment Principles
Before administering treatment, refer to section 4.1. Carefully
follow the guidelines presented there.
•
Before treating patients with excessive facial hair growth, see
section 4.6.6.
•
Treatment courses for hair removal vary and are dependant
upon the reactions of individual patient and area being treated.
However, they typically consist of 6-10 sessions performed
every 4-8 weeks.
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OPERATION AND TREATMENT PROTOCOLS
•
Treat the area again only when at least 30% regrowth has
occurred.
•
As treatment progresses, sessions may be spaced further
apart.
•
Set the initial energy level according to test results.
•
Energy levels should be reevaluated during each treatment and
for each treatment area.
•
There are 2 handpiece options, basic and extra large. The
extra large handpiece is recommended to treat large treatment
areas such as; legs, back and chest.
•
Perform one complete pass of the treatment site during each
session.
•
Apply ice (non-humid), such as an ice pack , to the site of the
next pulse before applying the pulse.
•
As treatment progresses, the remaining hair will turn lighter in
color and texture. Raise the energy levels accordingly.
•
Energy Adjustment for Fine Hair – If the chosen energy level
provides expected results on most treated areas, but is not
sufficiently effective on fine hair, energy may be increased to
reach required results on those treatment areas.
•
In all cases, hair must be darker than the skin (even slightly) for
successful treatment.
•
The Area Adaptors can be used when treating small areas
such as the toes, fingers or upper lip. They may only be used
on the basic handpiece.
•
Perform maintenance treatments as needed.
4.6.6.
Considerations for Feminine Facial Hair
Facial hair is generally obstinate and one of the hardest conditions to
treat for successful long term removal. Often caused by chronic or life
Mistral User Manual
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stage hormonal imbalances, it is important to understand that light
based treatments do not treat the underlying causes of these
imbalances and can at best offer temporary cosmetic relief.
Therefore when treating unwanted facial hair it is crucial to correctly
set the patient’s expectations and be very clear about anticipated
outcomes.
The purpose of this section is to share additional protocols that may
help improve treatment results and client satisfaction. Keep in mind
that in most cases, the underlying cause is unclear. This hair removal
treatment is cosmetic only and not a permanent solution.
1. Assessing the Client – Some symptoms that may indicate if a
woman's hair growth is related to a hormonal imbalance are:
•
Irregular menstruation
•
Obesity
•
Deepening of the voice
•
Small breast size
•
Baldness or sparse hair
•
Menopause or post pregnancy
•
Buffalo hump (Cushings Syndrome)
Clients with excessive facial hair combined with any of the above
symptoms should undergo an endocrine exam. If hormonal
imbalances are present, the client should be advised to pursue
medical treatment for their condition, if possible.
If there is no indication of hormonal imbalances or if the physician
has decided not to treat the condition, you may attempt to provide
relief from symptoms with LHE treatment. However, accepting
patients with the following diagnosed medical conditions should be
done with extreme caution and with clear warnings about
expectations.
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•
Hirsutism
•
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OPERATION AND TREATMENT PROTOCOLS
•
Medication or any physical conditions (such as polycystic
ovaries) that might influence hair growth
2. Setting Expectations – The patient should be informed that; the
number of treatments needed for acceptable hair removal cannot
be pre defined, additional maintenance treatments may be
required, and due to their medical condition, acceptable results
may not be achievable at all.
3. The Treatment Course – The recommended treatment course
should be determined based on what type of hair removal method
the patient used before beginning LHE treatments and how often
they
applied
it.
Refer
to Table
9 for
treatment
course
recommendations.
Note: Since it is strongly recommended that patients do not use
any other method of hair removal while undergoing LHE
treatments, the initial frequency of each treatment course takes
into consideration the patients desire to be hair-free, previous
methods of removal and hair growth cycles.
Table 9: Treatment Course Recommendations
Method Used Before
LHE Treatment
LHE Treatment Course
Waxed once in 3 weeks
Every 3-4 weeks, then gradually lengthen the interval
as needed (after 30% regrowth occurs)
Tweezed every week
Every 1-2 weeks for the first 1-2 months, then
gradually lengthen the interval to 3-4 weeks and
longer as needed (after 30% regrowth occurs)
Tweezed every day
1-2 times per week for the first 1-2 months and , then
gradually lengthen the interval to 2-3 weeks and
longer as needed (after 30% regrowth occurs)
4. Maintenance – Performed every 6 months as necessary.
5. Early Termination – Interim treatment results should be evaluated
after 4-7 treatments, depending on the case. If the practitioner
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does not observe at least 30% reduction of hair they should
consider, together with the patient, the possibility of early
termination.
6. Special Note About Vellus Facial Hair – Do not attempt to
remove vellus facial hair as induced hair growth may result.
7. Photo History – It is highly recommended that base line pictures
be taken before the first treatment and periodically throughout the
treatment course. This photo history may be presented as part of
the consent form.
4.6.7.
Post-Treatment Care
Observations - mild redness in the treatment area is normal and can
last anywhere from a few hours to a few days. Although some hairs
remain intact, most bleached and/or burned hairs usually fall out within
two weeks of treatment.
On the night following treatment, patients should avoid bathing in hot
water, or applying any harsh topical that might irritate the skin, such as
skin peels. They should be instructed to cleanse skin with lukewarm
water and gentle soap, and hydrate it with a suitable moisturizer.
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OPERATION AND TREATMENT PROTOCOLS
4.7.
Acne Treatment
Warning: Make sure you have the proper handpiece for AC treaments
4.7.1.
Clinical Background
LHE Acne phototherapy is based on the process of destruction of the
Propionibacterium acnes (P. acnes). P.acnes are slow growing
anaerobic bacteria which develop in blocked follicles, and produce
porphyrins as part of their normal metabolism. Exposure of porphyrins
to visible light results in a photodynamic reaction of these compounds,
and destruction of the P. acnes.
Fifty subjects with mild and moderate inflammatory acne, including
pustular inflammatory acne, participated in a multicenter blinded
controlled study of LHE acne clearance. The subjects were Fitzpatrick
skin Types I-IV.
Based upon a pre-treatment test on each subject, the highest energy
level that showed no side effects in that patient was used for
treatment.
Results: A mean decrease of 23.1 lesions (60.2%) was achieved
between the baseline and the end of the follow-up period compared to
a mean increase of 6.2 lesions (32.4%) for the control. All side effects
were minor and transient.
In another study, good clearance (over 60%) of non-inflammatory and
inflammatory lesions was observed. This clearance continued to
improve 2 months following the last treatment, reaching a 90%
decrease in lesion count from baseline.
4.7.2.
Indications
The Mistral AC handpiece is intended to provide phototherapeutic light
to the body. The Mistral AC handpiece is generally indicated to treat
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dermatological conditions. The Mistral AC handpiece is specifically
indicated to treat mild and moderate inflammatory acne which includes
treatment of pustular inflammatory acne in patients with Fitzpatrick
skin types I-VI.
4.7.3.
Contraindications
Mistral should not be used for acne treatments on patients who:
•
Are under 12 years of age.
•
Are pregnant or lactating.
•
Have tanned by sun or artificial tanning machine within the last
21 days.
•
Have a tattoo or permanent makeup in the treatment area.
•
Have abnormal skin conditions due to differnet diseases,
conditions (e.g. diabetes) or medicinal intake.
•
Have a history of skin disorders such as vitiligo or psoriasis in
the treatment area.
•
Have a history of local skin infections.
•
Have been treated with isotretinoin (Accutane) within the past 6
months.
•
Have used any medications, herbal preparations or chemicals
that cause photosensitivity within the past 6 weeks. These
include but are not limited to gold therapy, tetracycline or sulfa
drugs, and certain psychiatric medications.
In case of uncertainty regarding photosensitizing side-effects,
have the patient consult their physician.
•
Suffer from epilepsy.
•
Have diseases related to photosensitivity, such as Porphyria,
Polymorphic Light Eruption, Solar Urticaria, Lupus and other
autoimmune diseases.
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•
Have a history of herpes outbreaks in the treatment area,
unless the patient has consulted their physician and received
prophylaxis treatment prior to treatment.
•
Have a history of skin cancer or patients who have areas of
potential skin malignancies.
•
Have received chemotherapy or radiotherapy treatments
within the past 5 years should not be treated without their
acting physician's consent.
•
Have been on a steroid regimen (i.e. asthma) for the last 3
months.
•
Have an active implant, such as a pacemaker, incontinence
device, insulin pump, etc.
•
Have any other condition which in the practitioner’s opinion
would make it unsafe for the patient to be treated.
4.7.4.
Pre-Treatment Test – Acne Clearance
Set the energy level for the first pulse according to the table below. For
example, if the patient is skin Type II, the energy level for the first test
pulse should be set at 20.
Table 10: Energy Level Setting - AC
I
II
III
IV
V
VI
1st Pulse
25
20
15
10
3
0
2nd Pulse
30
25
20
15
5
3
3rd Pulse
35
30
25
20
8
5
The appropriate energy setting is the highest possible energy level that
causes mild redness to the skin and disappears within a few hours
after test.
If the required reaction in the target area is observed, this is the
appropriate energy level for treatment. If this required result does not
appear increase the energy level according to Table 10 until the
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required result is observed. Typically, it is advisable to wait a minimum
of 30 seconds between test pulses to determine the skin’s reaction.
Test pulses should be administered on adjacent spots.
If the required result is not observed immediately following or within 24
hours after the test, you have not yet reached the optimum level for the
treatment area. There is no need for further testing. As you begin
treatment, continue to raise the energy level by increments of 3 units
until the required results are observed. This often means raising the
level above those recommended in the table.
If at any point there is an adverse reaction, lower the energy level to
the next highest level that did not cause an adverse effect. Resume
treatment only after the skin has completely healed.
4.7.5.
•
Treatment Principles
Before administering treatment, refer to section 4.1. Carefully
follow the guidelines presented there.
•
The patient should be advised not to use retinoids or
medicated topicals during the treatment course.
•
Set energy according to test results.
•
Treating the lesions only, administer pulses on the treatment
area from right to left allowing no more than 5% overlap
between pulses. Stacking/overlapping can cause crusting or
blisters which can lead to some transient pigmentary changes.
After emitting the pulse, remove the Handpiece, hold it in the
air to cool and apply the next pulse only when the system is
fully charged and is in the "Ready" mode. Placing the
Handpiece on the skin prior to the signal indication will pre-heat
the skin and may cause unwanted side effects. After covering
the entire area, wait 5 minutes to allow the skin to cool and
repeat the procedure.
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OPERATION AND TREATMENT PROTOCOLS
•
Treatment Intervals – for optimal results patients should
complete a full treatment course of at least eight (8) sessions.
Treatments should be administered twice a week for a period
of at least four (4) weeks.
•
Please note, during the treatment course that due to a
response to treatment, slight aggravation of symptoms may
occur due to inflammatory response after 3-4 treatments. This
is a natural part of the healing process and will resolve itself
within days.
•
Adaptors –The Mistral handpiece has 3 optional adaptors: 2
Medium size-(13x50/13x35mm) and a Small area- (13x12mm).
You may wish to use the small adaptor on single lesions.
•
No energy adjustment is required while changing the adaptors
•
Post
treatment
recommendations
care
–
for
post
Refer
to
treatment
section
4.1
observations
for
and
interventions.
•
Perform maintenance treatments as needed.
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4.8.
Psoriasis Treatment
Warning: Make sure you have the proper handpiece for
psoriasis treaments
4.8.1.
The
mistral
Clinical Background
psoriasis
treatment
relayes
upon
selective
photothermolysis in which emition of green and yellow light emitted by
the Psoriasis Care Handpiece coagulates the capillaries which feed
the psoriatic lesions. Mistral also emits a pulse of heat which reduces
swelling and inflammation and relieves pruritus.
Thirteen patients participated in a controlled study. Patients received
two therapy regimens in parallel; LHE treatments plus salicylic acid
20% and salicylic acid cream alone as control. Treatments were
applied two times a week spread evenly over a 4-6 week period.
In eleven patients who completed the treatment regimen, average
global PSI score for the treated sites was reduced by 65%. In contrast,
on the control sites average global PSI score was reduced by only
7.4%. Six patients (55%) had a significant improvement of 70%
reduction or above in their PSI score, ten patients (91%) had a 50% or
above reduction while only one patient had a poor response (12.5%
reduction in global PSI).
It was concluded that LHE selective photothermolysis, combined with
salicylic acid, appears to be a practical modality for the treatment of
mild to moderate psoriasis. Patients experience only mild discomfort
with no convalescence downtime.
4.8.2.
•
Psoriasis Treated with Mistral
Plaque Psoriasis
Plaque psoriasis, the most common form of the disease is
characterized by well-defined patches of rough textured, red, skin with
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OPERATION AND TREATMENT PROTOCOLS
a white, flaky layer over the surface. About 80% of people with
psoriasis have this type. Plaque psoriasis can appear on any skin
surface, although the knees, elbows, scalp, trunk and nails are the
most common locations.
Figure 28: Plaque Psoriasis
4.8.3.
Indications
The Mistral PSOR handpiece is intended to provide phototherapeutic light to
the body. The Mistral PSOR handpiece is generally indicated to treat
dermatological conditions and is specifically indicated to treat mild and
moderate plaque psoriasis, which includes the treatment of patients with
Fitzpatrick skin types I-VI.
4.8.4.
Contraindications
•
Under 18 years of age
•
Are pregnant or lactating
•
Have tanned by sun or artificial tanning machine within the last
21 days.
•
Have a tattoo or permanent makeup in the treatment area.
•
Have a history of abnormal skin conditionsdue, for example, to
diabetes or other diseases.
•
Have a history of inflammatory skin conditions other than
psoriasis in the treatment area.
•
Have a history of local skin infections.
•
Have been treated with isotrentinoin (Accutane) within the past
6 months
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•
Have used any medications, herbal preparations or chemicals
that cause photosensitivity within the last 6 weeks. These
include, but are not limited to, gold therapy, tetracycline or sulfa
drugs and certain psychiatric medications.
In case of uncertainty regarding photosensitivity side effects,
have the patient consult their physician.
•
Suffer from epilepsy.
•
Have diseases related to photosensitivity, such as Porphyria,
Polymorphic Light Eruption, Solar Urticaria, Lupus and other
autoimmune diseases.
•
Have a history of herpes outbreaks, unless the patient has
consulted their physician and received prophylaxis treatment
prior to treatment.
•
Have a history of skin cancer or patients who have areas of
potential skin malignancies.
•
Have received chemotherapy or radiotherapy treatments within
the past 5 years should not be treated without their acting
physician's consent.
•
Have been on s steroids regimen (e.g. asthma) over the last 3
months
•
Have an active implant, such as a pacemaker, incontinence
device, insulin pump, etc.
•
Have any other condition which in the practitioner’s opinion
would make it unsafe for them to be treated
4.8.5.
Pre-Treatment Considerations
During the initial client visit, the LHE psoriasis practitioner should assess the
areas to be treated and address the following issues:
•
Verify that the client does not meet any of the exclusion criteria.
•
Inform the client that there may be some discomfort associated
with the treatment.
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•
Inform the client that transient erythema, edema or blistering
may appear immediately after treatment.
•
Inform the client that LHE psoriasis treatment involves several
sessions and that he or she should be willing to complete the
full treatment course.
•
Inform the client that there is a small risk of possible adverse
side effects such as changes in texture and hypo-or hyperpigmentation of the skin and that these changes are usually
transient.
•
If you chose to add salicylic-acid in combination with the
treatment regime ,make sure that the patient uses it on a
regular daily basis during the entire treatment course. The
salicylic acid should be applied a few hours from the treatment,
preferably before the treatment administration .
•
Have the client sign your consent form prior to treatment
4.8.6.
Pre-Treatment Preparation
1
Clean - Clean the treatment area to remove any dirt or makeup.
DO NOT USE ALCOHOL OR ACETONE!!
2
Dry - Dry the skin surface to be treated.
NEVER ALLOW ANYTHING WET NEAR THE TREATMENT AREA!!
3
Cover – Cover the surrounding, healthy skin tissue with a white
sticker.
DO NOT USE FLAMMABLE MATERIAL!!
When treating a well defined psoriatic lesion (plaque), treat only
4
the lesion area, not the surrounding skin. The surrounding skin
should be covered with a white nonflammable sticker.
Warning: Do not treat the area around the eyes.
5
Testing Procedure
Perform the pre-treatment preparations. Select a section on the
treated area and conduct a test by applying 3 different energy
levels as explained below.
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Table 11: Energy Level Setting - PSOR
Skin Types I-III
Skin Types IV
Skin Types V-VI
25
20
10
Pulse
30
25
15
3 Pulse
35
30
20
st
1 Pulse
2
nd
rd
•
Select energy level for first pulse according to Table 11.
•
•
Select energy level for second pulse according to Table 11
•
•
Trigger a pulse on a skin patch in the test site.
Trigger a pulse close to the first pulse.
Select energy level for third pulse according to. Table 11
•
Trigger a pulse close to the second pulse.
Schedule a follow up visit within 48-72 hours after the test and examine the 3
patches. The correct energy level will be the one that produced redness and
erythema without blistering. If all energy levels are suitable treat with the
higher one.
4.8.7.
•
Treatment Procedure
Skin Preparation - If the client has extremely rough skin,
instruct your patient to use Salicylic Acid to remove the scales
a few hours prior to treatment.
•
Air Circulation and Cooling - After emitting the pulse, wait for 1
second, lift the Handpiece from the skin, and wait until the
green Ready indicator is activated, indicating that the
Handpiece has cooled and it is safe to treat the client. Placing
the handpiece on the skin prior to the Ready indication will preheat the skin and may result in unwanted side effects.
•
Handpiece position - Administer pulses so the full treatment
area is covered. The Handpiece tip should be pressed lightly
on the skin’s surface. If needed use the small/medium area
adaptor.
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•
Treatment method - Set the energy level according to test
results. Administer pulses on the treatment area from right to
left sequentially having no more than 5% overlapping between
pulses to avoid crusting or blisters. After pulsing the whole
area, wait 5 minutes to allow skin cooling and repeat the
procedure one more time.
•
Treatment Intervals – Treatment should be applied twice a
week for at least 4-6 weeks. It is recommended that treatments
be spread evenly during the week (e.g. 3-4 days between
treatments).
•
If no results are seen after 3 treatments increase energy by
10%.
•
Stop treatment immediately if any of the following occurs:
Extreme Redness, Blistering, or Burning. Resume treatment
only after the skin has completely healed.
4.8.8.
•
Post Treatment Considerations
Observations - Redness may be noticed in the treated area
and can last from several hours up to a few days. Though most
people treated do not feel any significant discomfort, a soothing
cream (e.g. Aloe Vera) may be used if necessary.
•
Interventions - If blistering occurs, slightly reduce the energy
level. Do not readminister treatment to the same place until the
blister has resolved.
•
Salycilic acid should not be applied on iritated skin.
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4.9.
Skin Tightening
4.9.1.
Indications
Mistral ST treatments are indicated for patients in good general health,
18 years of age or older, for the treatment of finelines and wrinkles.
Mistral may be used to treat the face, neck, and abdomen.
Warning: Do not connect any other handpiece to the system when
using the ST handpiece.
4.9.2.
Contraindications
Mistral should not be used on patients who:
• Are pregnant or lactating.
• Have tanned by sun or artificial tanning machine within the
last 21 days.
• Have a tattoo or permanent makeup in the treatment area.
• Have abnormal skin conditions due to differnet diseases,
conditions (e.g. diabetes) or medicinal intake.
• Have a history of skin disorders such as vitiligo or psoriasis
in the treatment area.
• Have a history of local skin infections.
• Have been treated with isotretinoin (Accutane) within the
past 6 months.
• Have used any medications, herbal preparations or
chemicals that cause photosensitivity, within the past 6
weeks. These include but are not limited to gold therapy,
tetracycline
or
sulfa
medications.
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Revision 07, August 2009
drugs,
and
certain
psychiatric
OPERATION AND TREATMENT PROTOCOLS
In case of uncertainty regarding photosensitizing sideeffects, have the patient consult their physician.
• Suffer from epilepsy.
• Have
diseases
related
to
photosensitivity,
such
as
Porphyria, Polymorphic Light Eruption, Solar Urticaria,
Lupus and other autoimmune diseases.
• Have a history of herpes outbreaks in the treatment area,
unless the patient has consulted their physician and
received prophylaxis treatment prior to treatment.
• Have a history of skin cancer or patients who have areas of
potential skin malignancies.
Have received chemotherapy or radiotherapy treatments
•
within the past 5 years should not be treated without their
acting physician's consent.
• Have been on a steroid regimen (i.e. for asthma) over the
last 3 months.
• Have an active implant, such as a pacemaker, incontinence
device, insulin pump, etc.
• Have any other condition which in the practitioner’s opinion
would make it unsafe for them to be treated.
4.9.3.
Pre-Treatment Test –
Skin Tightening Application
Table 12: Energy Level Setting - ST
Skin Type
I
II
III
IV
Medium
Pulse Width
V
VI
Long
1st Pulse
40
30
30
20
20
2nd Pulse
50
45
35
25
25
3rd pulse
60
55
50
40
30
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Set the energy level for the first pulse according to Table 12. For
example, if the patient has skin Type III, the pulse width should be
set at medium with the energy level set at 30. The appropriate
energy level has been reached if any of the following required
reactions are observed immediately following the pulse:
• Deep heat sensation
• Erythema - immediately or within 10-15 minutes after pulsing.
The erythema should be subtle and diffuse, not reflecting the
shape of the lamp opening.
• Slight Edema
Wait a minimum of 30 seconds between test pulses to determine the
skin’s reaction.
If you do not observe any of the required results in the test area,
increase the energy level according to the table until you observe the
required reaction/s. Test pulses should be applied on adjacent areas
in the intended treatment area.
If the required result is not observed immediately following or within
24 hours after the test, you have not yet reached the optimum level
for the treatment area. As you begin treatment, continue to raise the
energy level by increments of 5 until the required results are
observed.
This
may
mean
raising
the
level
above
those
recommended in the tables.
If at any point there is an adverse reaction, lower the energy level to
the highest level that did not cause this adverse effect. Resume
treatment only after the skin has fully healed.
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OPERATION AND TREATMENT PROTOCOLS
4.9.4.
•
Treatment Principles
Do not connect any other handpiece to the system when
using the ST handpiece. A handpiece from another
application will not be recognized by the system and a
second ST handpiece will reduce the energy level by 50%,
making the treatment ineffective.
•
When applying the pulse, simultaneously press the foot
switch and the pulse switch for the total duration of the pulse
(20-45 seconds).
•
You do not need to keep pressing the pulse switch on the
handpiece for the entire length of the pulse. However, you do
need to keep the foot switch depressed until the end of the
pulse.
•
A flashing LED will appear during the application of the pulse.
When the pulse is finished, an audible signal will sound to
indicate the end of the pulse. Since the pulse is in the infrared spectrum, you will not be able to see it during emission.
You may rely on the flashing LED and audio signals to mark
when the pulse begins and ends.
•
Keep the handpiece in place for the entire duration of the
pulse, unless the aptient experiences extreme discomfort.
•
A full treatment course generally consists of 6-10 bi-weekly
sessions carried out over 3-5 weeks.
•
Before administering treatment, refer to section 4.1. Carefully
follow the guidelines presented there.
•
Set the energy level according to test results.
•
You may apply non-humid ice , such as an ice pack , to the
site of the next pulse to enhance patient comfort.
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•
The appropriate energy level for treatment is one that causes
only mild redness that disappears quickly after the pulse.
•
Perform two passes. Wait a minimum of 5 minutes between
the passes to prevent over heating the skin.
•
Maintenance treatments should be performed as needed.
4.9.5.
Post Treatment Care
In addition to post treatment care described in section 4.1, advise
the patient to avoid bathing in hot water, facial peeling creams or
preparations that may irritate the skin for 24 hours following
treatment. The patient should also understand that avoiding sun
exposure and artificial tanning devices for a period of not less than
one month following treatment is particularly important for the
success of skin rejuvenation treatments.
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5.
5.1.
MAINTENANCE
Cleaning Instructions
CAUTION
Before cleaning the handpiece and main unit, always turn
the unit off, disconnect it from energy and wait a minimum
of 5 minutes.
5.1.1.
Main Unit
Cleaning of the main unit (system console) should be done with a
soft nonabrasive cloth, moistened with mild detergent or soap
suitable for external cleaning of electrical equipment. Avoid getting
cleaning solution into the machine. Spray directly into the cloth and
not onto the unit itself. Do not use cleaning solutions that contain
ingredients that may harm plastic, such as ammonia, acetone,
hydrochloric acid (HCI), chlorine bleach etc.
5.1.2.
Handpiece
During treatment, especially for hair removal, debris accumulates on the
lamp. This may affect performance and the life of the lamp. Use the
supplied cleaning tool to clean the lamp after each treatment (Figure 29).
Tip B
Use this end to clean
between the lamps
Tip A
Use this end to clean between
the lamps and reflector.
Figure 29
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1.
Put 2 drops of alcohol on the sponge part of the cleaning tool
(Figure 30)
Figure 30
2. Use Tip B to gently rub along the length of the lamps between the
two lamps until the debris is removed (Figure 31).
Figure 31
3. Use Tip A to gently rub along the length of the lamps between the
lamp and reflector until the debris is removed (Figure 32)
IMPORTANT: Do not let the sponge part of the cleaning tool touch
the reflector. The black part will automatically clean the reflector as
you clean the lamp (Figure 32).
Figure 32
4. Gently remove the remaining debris with a clean, damp lint-free cloth
or a cleaning wipe.
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OPERATION AND TREATMENT PROTOCOLS
5. Make sure the lamp and reflector are completely dry before the next
treatment.
5.2.
Parts & Attachments
5.2.1.
Handpiece Replacement
The handpiece must be replaced every 50,000 pulses. Remove the
handpiece from the system and return it to your Radiancy
representitive for a replacement.
5.2.2.
Area Adaptors
The Area Adaptors are used when treating different size and shape
areas.. For hygienic reasons, clean the area adaptor between each
patient with a soft, damp cloth, as you would the handpiece.
Figure 33: Area Adaptor
To install the Area Adaptor:
Hold the adaptor in one hand and the handpiece in the other. Place
the adaptor on the handpiece as shown in Figure 33. Align the two
tabs with the openings on the small ends of light unit. Gently press
until you hear a clicking sound signalling that the adaptor is firmly in
place.
To remove the Area Adaptor:
Hold the adaptor in one hand and the handpiece in the other and
gently pull off the adaptor
Mistral User Manual
73
CHAPTER 4
5.2.3.
Fuse Replacement
To replace the fuse and restore the energy after a fuse is blown, turn
off the unit and disconnect the system from the electrical outlet. Wait
5 minutes. Pull out the fuse drawer located in the back panel.
Replace the fuse and push the drawer back into position.
Fuse panel
Power Cord Inlet
Figure 34: Fuse Location
74
Revision 07, August 2009
6. ADVERSE EVENTS REPORT FORM
Date of the report ________________
In the case of any of the adverse events listed below, please complete this
form and send a copy to your distributor and Radiancy Ltd. no longer than
24-48 hours after you learn of the occurance. Retain a copy for your own
records.
Radiancy (Israel) Ltd.
5 Hanagar St., P.O. Box 7329
Hod Hasharon, 45240, Israel
FAX: 972-9-775-7511
[email protected]
Adverse Event - Any unwanted medical occurance in a subject whether or
not it is device related.
Outcomes attributed to the adverse event :
Hospitalization (mm/dd/yy) _______ / _______ / _______
Required intervention to prevent permanent impairment/damage
Disability or permanent damage
Death (mm/dd/yy) _______ / _______ / _______
Other serious (important medical events)
Submission of a report does not constitute an admission of fault or
that the medical personnel, facility, importer, manufacturer or product
caused or contributed to the event
Patient Information :
First Name: ____________________
Last Name: ____________________
Age:_____
Gender : Female
75
Male
Revision 07, August 2009
Treatment Administration :
Date of event: (mm/dd/yy) _______ / _______ / _______
Please specify device used:
Device Name: _____________________
Company: _________________________
Serial Number: _____________________
Where was the treatment done?
Name of Facility: __________________
Address: ________________________
________________________
________________________
Who performed the treatment?
Full Name: _______________________
Title: ________________________
Who is preparing and submitting this report?
Full Name: _______________________
Title: ________________________
What sort of treatment was performed ?_______________________
What was the treatment area:
___________________
First time the adverse effect was observed: (mm/dd/yy) _____ / _____ / ___
Date the adverse effect resolved: (mm/dd/yy) _______ / _______ / _______
Please describe in detail the event or problem. If there is not enough room,
continue on other paper and attach to report.
____________________________________________________________
____________________________________________________________
____________________________________________________________
____________________________________________________________
____________________________________________________________
____________________________________________________________
76
Revision 07, August 2009
Treatment discontinued?
Yes
No
If yes, provide an explanation for discontinuation:
____________________________________________________________
____________________________________________________________
____________________________________________________________
____________________________________________________________
Please attach and list all relevant documentation (patient file ,discharge
report ect.):
____________________________________________________________
____________________________________________________________
____________________________________________________________
Please include any other relevent patient history , including any preexisting
medical condition(s):
____________________________________________________________
____________________________________________________________
____________________________________________________________
Relation to the Treatment:
Event Outcome:
Probable
Resolved
Possible
Improved
Probably not
Unchanged
Not related
Worsened
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77
7.
TROUBLESHOOTING
Situation/Symptom
The system does not
turn on
(Numbers are not
shown on the display
and the lights are off)
Possible Cause
Solution
The “On/Off” switch on
the front panel of the
system is in the Off
position
Toggle the “On/Off” switch to
the On position.
Power disconnected
The Emergency Stop
button is pushed.
Blown fuse
The system starts but
the system’s cooling
unit has not turned on
The cooling unit was on
but later stopped
working
The “Ready” beep is
not heard when the
system is ready
A pulse is not triggered
when pressing on one
of the Handpiece pulse
switches
The Footswitch has
not been pressed to
activate the system’s
cooling unit
The Footswitch is not
connected or is
connected incorrectly
The Footswitch was
not pressed for the
past 60 seconds
Toggle the “On/Off” switch to
the Off position.
Check that the power cable is
plugged into the electrical
outlet and connected to the
main unit power inlet.
Turn towards the right, in the
direction of the arrows.
Check the fuse inside the fuse
drawer. Replace fuse if blown.
Press the Footswitch to
activate the system’s cooling
unit
Connect the Footswitch
Press the Footswitch to start
the system again
The “Mute” switch on
the LCD screen is On
Press the “Mute” button to turn
it Off
The Footswitch was
not pressed
Simultaneously press the
Footswitch and one of the
Handpiece pulse switches
The main unit has not
completed the
recharging cycle
One of the Handpiece
pulse switches was
pressed down before
pressing the
Footswitch
The handpiece is worn
out
Improper locking of
lamp into Handpiece
caused darkening of
contact points
Wait for the Ready indicator to
be activated on the LCD screen
Release the pulse switch on
the Handpiece. Then
simultaneously press and hold
the Footswitch and one of the
Handpiece pulse switches
Check the number of pulses
that were performed with the
handpiece. Replace If over
50,000 pulses.
Stop system operation. Call
Radiancy service immediately
Mistral User Manual
78
TROUBLESHOOTING
Situation/Symptom
Possible Cause
Solution
Darkened plastic near
the lamp on the
Handpiece
The Handpiece was
not lifted from the
treatment area after
each pulse
After each pulse, make sure to
lift the Handpiece away from
the treatment area. Hold the
Handpiece so that air can
freely enter the lamp for at
least 10 seconds before
applying the next pulse
The patient feels that
the handpiece placed
on the treatment site is
hot prior to triggering a
pulse
The cooling airflow is
blocked because hair
has accumulated in
the filter
Replace the filter
The cooling air-flow is
weak
Rupture in the
Handpiece spiral tube
Replace the Handpiece
8.
MISTRAL SERVICE
Radiancy
Israel
Radiancy (Israel) Ltd.
5 Hanagar St., P.O. Box 7329
Hod Hasharon, 45240, ISRAEL
Radiancy
North America
Radiancy Inc.
40 Ramland Road South, Suite 200
Orangeburg, NY 10962, USA
Tel: 972-9-775-7500
Fax: 972-9-775-7511
[email protected]
Toll Free number:
888-661-2220
Tel: 1-845-398-1647
Fax: 1-845-398-1648
[email protected]
Mistral User Manual
79
9.
WARRANTY
After receiving Mistral and operating it for the first time, please fill out
this Warranty Card and send to:
Radiancy (Israel) Ltd.
5 Hanagar St., P.O. Box 7329
Hod Hasharon, 45240
Israel
Mistral™ Warranty Card:
User Information:
Name:
Street:
City:
System Details:
Serial Number:
Purchase Date:
Comments:
State:
Zip Code:
Tel:
Fax:
Mobile:
E-mail:
Was the system received without visible external damage?
Yes
No. Please describe:
Did the system operate properly immediately after installation?
Yes
No. Please describe:
Mistral User Manual
80
RADIANCY INC.
40 Ramland Road South, Orangeburg, Suite 200, New York 10962, USA
Tel: +1 845 398 1647 Fax: +1 845 398 1648 Toll Free: +1 888-661-2220
www.radiancy.com
RADIANCY INC ▪ RADIANCY LTD
© 2007-2009 Radiancy Inc. All Rights Reserved.
2011580 / Rev. 07 / August 2009